StacksVerified U.S. regulatory reference

21 CFR §524.1195

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.
  2. (b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
  3. (c)Conditions of use—(1) Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal.
    1. (2)Indications for use. For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.